[关键词]
[摘要]
目的 评价硫酸长春新碱脂质体的质量。方法 采用pH梯度法制备硫酸长春新碱脂质体。透射电镜观察脂质体的外观形态, 阳离子交换树脂柱法测定包封率, 并考察其pH值、粒径、Zeta电位、稳定性及体外释放规律。结果 形态学观察结果显示, 脂质体均匀圆整度良好。硫酸长春新碱脂质体粒径为120 nm左右, Zeta电位约为10 mV, 包封率均在90%以上。光照、4 ℃、18 ℃、25 ℃条件下, 脂质体各项指标无显著变化。40 ℃条件下, 包封率明显降低。结论 本法准确, 操作简便, 可用于硫酸长春新碱脂质体的质量评价。
[Key word]
[Abstract]
Objective To evaluate the quality of Vincristine Sulphate Liposome. Methods Vincristine sulphate was encapsulated in the liposomes using the pH gradient-dependent remote loading technique. The morphological examination of liposomes was observed with transmission electron microscopy. The encapsulation efficiency was determined by cation exchange resin column. Their pH value, particle size, Zeta potential, stability, and in vitro delivery of vincristine sulphate were investigated. Results The morphology of Vincristine Sulphate Liposome showed that liposomes were uniformity, good roundness. The particle size of the liposomes was about 120 nm, the Zeta potential was about 10 mV, and the encapsulation efficiency was above 90%. Vincristine sulphate liposomes did not occur significant changes under the light condition and at 4 ℃, 18 ℃, and 25 ℃ conditions. At 40 ℃, the encapsulation efficiency decreased. Conclusion The method is accurate and simple to evaluate the quality of Vincristine Sulphate Liposomes.
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[基金项目]
国家重大新药创制项目(2014ZX09507005-001)